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EMA positive opinion for ViiV’s cabotegravir

The drug is an injectable or tablet specifically developed for HIV prevention among certain individuals.

ViiV Healthcare – a company focusing on HIV treatments – has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for its cabotegravir therapy.

The drug is a long-acting (LA) injectable or tablet specifically developed for HIV prevention and is recommended in combination with safer sex practices for pre-exposure prophylaxis (PrEP). Ultimately, it is used with a view to reducing the risk of sexually acquired HIV-1 infection among high-risk adults and adolescents weighing at least 35kg.

Across Europe, sound progress has been made in the delivery of HIV treatment and prevention services, with a continuous decline in the incidence of new HIV cases witnessed. There are, however, 100,000 new diagnoses each year and, if approved, cabotegravir will become the only prevention option for people at risk of HIV acquisition that is administered as few as six times every year.

The positive opinion was backed by data from two international phase 2b/3 randomised, multi-location, double-blind, trials: HPTN 083 and HPTN 084. This research analysed the efficacy and safety of cabotegravir LA for PrEP in HIV-negative men who have sex with men, transgender women and cisgender women who are at increased risk of being exposed to HIV.

Consequently, the trials demonstrated that cabotegravir LA for PrEP was superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). Indeed, participants taking cabotegravir LA experienced a 69% lower rate of HIV acquisition compared to FTC/TDF tablets in the HPTN 083 trial and a 90% lower rate of HIV acquisition when contrasted to FTC/TDF tablets in the HPTN 084 study.

Kimberly Smith, head of research and development at ViiV Healthcare, reflected: “The expansion of prevention options is critical if we are to end the HIV epidemic. Long-acting options have the potential to play an important role in reducing challenges such as inconsistent adherence to taking daily pills and stigma associated with oral PrEP use that can be faced by people who could benefit from PrEP.”

She added: “At ViiV Healthcare we are at the forefront of cutting-edge science, developing innovative solutions to address the biggest unmet needs in HIV prevention. With the CHMP’s positive opinion, we are hopeful that people in Europe will soon be able to benefit from greater choice.”

Under the name Apretude, cabotegravir LA for PrEP is already approved for use across the US, Australia, South Africa, Zimbabwe, Malawi, Botswana and Brazil.